NCT02656433

tES With Random Noise Stimulation Applied to Children With Brain Injury

Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Spanish Foundation for Neurometrics Development · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50% females will participate in an interventional study in two groups: placebo and experimental group. Placebo group will only receive traditional treatment with physiotherapy and the Experimental or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.

Detailed description

In this Interventional Study with Double Blind Assignment to Placebo and Experimental Group, Gross Motor Function Measure (GMFM) and Neurophysiological are the parameters measured with EEG amplifier before and after 30 sessions. Work hypothesis is that the tRNS Group will present better motor functionality after 30 sessions of 30 minutes of duration of electrical brain stimulation administered during physiotherapy exercises 2 days per week than the Group that only receives treatment with physiotherapy during 30 minutes 2 days per week without tRNS.

Conditions

• Brain Injury
• Motor Skills Disorders

Interventions

Type	Name	Description
DEVICE	Transcranial Random Noise Stimulation	A special Helmet supply weak electrical currents in the head
OTHER	Physiotherapy	Standard of care physiotherapy aimed to the motor impairment the subject presents

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-09-13
• Completion: 2023-01-31
• First posted: 2016-01-15
• Last updated: 2024-05-07

Locations

1 site across 1 country: United Kingdom